CHINA Trends and Developments Contributed by: Hanshuo Zhou, Xiaoyun Wang and Taige Shi (Casper), Jingtian & Gongcheng
development, AI systems are not yet authorised to substitute for the professional judgement of licensed physicians or pharmacists in critical clinical decisions, including diagnosis, prescrib- ing, and prescription review. Human oversight remains both a legal requirement and a clinical safeguard. AI+ drug development AI is reshaping drug development by dramatical- ly speeding up traditionally time- and resource- intensive processes. Its most transformative impact has been in early stage research – drug discovery, candidate screening, and clinical trial design – where the ability to analyse vast data- sets accelerates decision-making and targets promising compounds more precisely. This shift has unlocked unprecedented opportunities for innovation and efficiency across the pharmaceu- tical sector. However, these advances bring complex regu- latory questions. Aligning AI-generated clinical trial protocols with Good Clinical Practice (GCP) standards is a major hurdle: if algorithmic rec- ommendations lead to flawed trial designs, lia- bility issues can arise, particularly when adverse events (AEs) or serious adverse events (SAEs) occur. Moreover, AI-driven R&D depends on large vol- umes of sensitive personal data – from patient medical histories and health records to genomic sequences. Collecting, storing, analysing, and sharing this data must fully comply with China’s data privacy and cybersecurity laws, with special attention to cross-border transfer requirements. Finally, the use of AI for target identification and compound screening raises critical intellectual property concerns. As AI-generated discover- ies play a growing role in R&D outcomes, com-
panies must craft IP frameworks that clearly address inventorship, data ownership, and the enforceability of AI-driven inventions. Pharmaceutical trial data protection nearing implementation China is moving closer to implementing a for- mal regulatory framework for pharmaceutical trial data protection – an exclusivity mechanism designed to operate independently of the patent system. This regime grants originator compa- nies a period of data exclusivity following drug approval, during which competitors are prohib- ited from relying on the originator’s undisclosed clinical trial data to support their own marketing authorisation applications. The system aims to offer an additional layer of commercial protec- tion to encourage pharmaceutical innovation. While the principle of protecting “undisclosed trial data submitted by manufacturers or distrib- utors of drugs containing new chemical entities” is already embedded in China’s Drug Adminis- tration Law, specific implementing rules have yet to be enacted. However, the release in March 2025 of two key draft instruments – the Draft Implementing Regulations of the Drug Admin- istration Law and the Draft Procedures for the Protection of Pharmaceutical Trial Data – signals that detailed enforcement mechanisms are now nearing finalisation. Data compliance and personal information protection in digital health The rapid growth of China’s digital health sec- tor – driven in large part by the integration of AI technologies into healthcare delivery – has dramatically increased the volume and com- plexity of data collection, storage, processing and transmission. As medical data increasingly crosses borders, companies must navigate a layered set of regulatory concerns, including
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